Regulation (EU) 2017/745 · Regulation (EU) 2017/746
EU medical device regulations MDR and IVDR
The MDR and IVDR are two parallel legal frameworks. The correct route starts with the product’s intended purpose, not with a preferred risk class or a registration form.
Manufacturers must determine which regulation applies, classify the product, build the required evidence, complete the applicable conformity assessment and maintain compliance throughout the product lifecycle.
The regulatory concept
CE conformity assessment is not product registration
The normal EU pathway does not end in a central authority granting a generic “medical-device approval.” The manufacturer demonstrates conformity with the applicable regulation and, where required, a notified body assesses the relevant quality system and technical documentation.
After the applicable assessment is complete, the manufacturer signs the EU declaration of conformity and affixes the CE marking. Actor and product data submitted to EUDAMED support identification and transparency; that submission does not replace conformity assessment.
Qualify
Confirm that the product falls within the MDR or IVDR.
Classify
Apply the legal rules to the intended purpose and design.
Demonstrate
Build technical, clinical or performance and quality evidence.
Maintain
Use post-market data to keep conformity current.
Two connected frameworks
Choose the regulation before building the dossier
Product qualification depends on the intended purpose, claims, mode of action, specimen or patient interface and the information the product is intended to provide.
Regulation (EU) 2017/745
Medical devices
Covers devices intended for human beings whose principal intended action is not achieved by pharmacological, immunological or metabolic means. It also covers certain products without an intended medical purpose listed in Annex XVI.
- Risk classes
- I, IIa, IIb and III
- Core evidence
- Clinical evaluation
- Applicable since
- 26 May 2021
Regulation (EU) 2017/746
In vitro diagnostic medical devices
Covers devices intended to examine specimens derived from the human body in vitro to provide medical information, including reagents, instruments, kits, software, calibrators, control materials and systems.
- Risk classes
- A, B, C and D
- Core evidence
- Performance evaluation
- Applicable since
- 26 May 2022
Conformity route
Build the route in the right order
Classification controls the assessment route, but it does not replace the broader work needed to demonstrate conformity with every applicable requirement.
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01
Define intended purpose
Fix the medical purpose, target population, user, environment, indications, limitations and operating principle.
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02
Qualify and classify
Select MDR or IVDR, document the applicable Annex VIII rules and identify any special provisions.
-
03
Build the evidence system
Connect risk management, GSPR, verification and validation, clinical or performance evidence, labelling and manufacturing controls.
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04
Complete conformity assessment
Use self-declaration where legally permitted or involve a notified body under the applicable assessment procedure.
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05
Declare conformity and apply CE
Issue the EU declaration of conformity, apply the CE marking correctly and complete the required actor, UDI and product-data steps.
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06
Control the lifecycle
Operate PMS and vigilance, update evidence and risk controls, manage changes and maintain current registration data.
Risk-based classification
The class changes the conformity-assessment route
Annex VIII rules must be applied to the concrete intended purpose and design. A product name or an existing competitor classification is not a sufficient rationale.
| Framework | Classes | Normal notified-body involvement | Evidence focus |
|---|---|---|---|
| MDR medical devices | I · IIa · IIb · III | Classes IIa, IIb and III; limited involvement for class Is, Im and Ir | Clinical evaluation, safety and clinical performance |
| IVDR diagnostic devices | A · B · C · D | Classes B, C and D; limited involvement for class A sterile | Scientific validity, analytical performance and clinical performance |
Self-declaration is limited
It normally applies to class I devices that are not sterile, measuring or reusable surgical instruments, and to class A IVDs that are not sterile.
Notified-body assessment
The scope and depth of assessment increase with risk and may include QMS review, technical-documentation sampling, type examination or product verification.
Additional procedures may apply
Companion diagnostics, class D IVDs, medicinal-substance combinations, animal tissues and certain high-risk devices may trigger consultation or verification procedures.
Regulatory responsibility
Market access depends on a controlled operator chain
The manufacturer remains responsible for the product. Other economic operators have distinct verification, cooperation and traceability obligations.
Manufacturer
Owns conformity, the QMS, technical documentation, evidence, CE marking, PMS, vigilance and corrective action.
EU authorised representative
Required for a manufacturer established outside the EU and appointed through a written mandate for the covered devices.
Importer
Verifies key compliance elements before placing a device from a non-EU manufacturer on the Union market.
Distributor
Checks specified information, protects storage and transport conditions and supports traceability and corrective action.
Evidence architecture
Conformity must be traceable, not merely asserted
The technical documentation should show how the released product, its claims, risks, verification and real-world information form one controlled system.
Quality management system
Design, supplier, manufacturing, change, complaint, CAPA and post-market processes proportionate to the product and organisation.
Risk management and GSPR
Applicable requirements mapped to design controls, risk controls, standards, tests and controlled evidence.
Technical documentation
Product definition, design and manufacturing information, benefit-risk rationale, verification, validation and supplied information.
Clinical or performance evidence
MDR clinical evaluation or IVDR performance evaluation aligned with the intended purpose and state of the art.
UDI and EUDAMED data
Controlled identifiers and actor, device and certificate data consistent with the declaration, certificates and released product.
PMS and vigilance
Proactive data collection, trend review, incident reporting, periodic outputs and feedback into risk and evidence updates.
Current implementation
Transition dates are conditional, not automatic extensions
Legacy-device provisions allow certain products to remain on the market during defined periods only when all applicable conditions are met. New devices and devices outside those provisions must comply fully with the MDR or IVDR.
Class III and relevant class IIb implantable devices
Other class IIb, class IIa and qualifying class I devices
Class D, class C, and class B or class A sterile respectively
Deadlines depend on continued legacy eligibility, timely notified-body application and agreement where required, QMS implementation, surveillance and absence of disqualifying significant changes.
Operational reality in 2026
The framework continues to evolve after the regulations apply
Consolidated legal texts, implementing acts and current MDCG guidance should be checked when a regulatory decision is made.
Four modules became mandatory on 28 May 2026
Actor registration, UDI/Device registration, Notified Bodies and Certificates, and Market Surveillance are now mandatory.
Review EUDAMED registrationArticle 10a creates an information duty
For covered devices, an anticipated interruption or discontinuation that may create serious harm or a risk of serious harm can trigger advance notification duties.
Open the Commission Q&AMDCG documents support application of the law
They express a common implementation understanding but do not replace the binding text of the MDR, IVDR or applicable implementing legislation.
Open current MDCG guidanceRegulatory starting check
Questions to answer before planning market access
If these points are not controlled, timelines and notified-body quotations are based on assumptions rather than a defined regulatory route.
Intended purpose
Medical purpose, target population, user, use environment, indications and limitations are fixed.
Qualification
The rationale identifies MDR, IVDR or another legal framework and addresses borderline issues.
Risk class
Every applicable Annex VIII rule has been assessed and the decisive rule is documented.
Conformity route
The applicable annex, notified-body need and any consultation or verification procedure are known.
Economic operators
Manufacturer, authorised representative, importer and distributor responsibilities are allocated.
Evidence plan
Technical, clinical or performance, biological, software, usability and other evidence needs are mapped.
QMS readiness
Required processes and records exist before design transfer, certification and commercial distribution.
Lifecycle plan
PMS, vigilance, PMCF or PMPF, periodic reporting, change control and registration maintenance are resourced.
Primary sources
Use the consolidated law and current Commission guidance
Regulatory decisions should be traced to the applicable legal provision. Guidance helps interpret and implement the requirements but is not the law itself.
Regulation (EU) 2017/745
Official MDR text on EUR-Lex
Regulation (EU) 2017/746
Official IVDR text on EUR-Lex
European Commission sector overview
EU medical-device framework and implementation topics
MDCG guidance
Current endorsed guidance organised by subject
EUDAMED overview
Current module status and implementation timeline
IVDR transitional provisions
Official Commission information on extended transition periods
In brief
Questions about the MDR and IVDR
Which regulation applies to my product?
The intended purpose and product characteristics determine the answer. The MDR generally applies to medical devices and Annex XVI products, while the IVDR applies to medical devices intended to examine human specimens in vitro for a medical purpose.
Does a medical device receive EU approval?
The normal route is conformity assessment followed by the manufacturer's EU declaration of conformity and CE marking. Notified-body involvement depends on class and product characteristics. EUDAMED registration is not a substitute for conformity assessment.
When is a notified body required?
Under the MDR, generally for classes IIa, IIb and III and for defined aspects of class Is, Im and Ir. Under the IVDR, generally for classes B, C and D and for the sterile aspects of class A sterile devices.
What must a non-EU manufacturer arrange?
A manufacturer established outside the EU must designate a sole EU authorised representative for the relevant devices. Importer requirements also apply when the product is placed on the Union market.
Can a legacy device use a transition date automatically?
No. Transitional provisions are conditional. Eligibility, notified-body application and agreement deadlines, QMS requirements, surveillance and change restrictions must all be checked for the specific device.
Does CE marking finish the compliance work?
No. The manufacturer must maintain the QMS and technical documentation, operate PMS and vigilance, update evidence and risk controls, manage changes and keep required actor, UDI and product data current.
From product concept to controlled route
Define the pathway before committing to the dossier
MDRC can assess qualification and classification, define the conformity route, map the required evidence and organise the manufacturer, authorised-representative, notified-body and EUDAMED workstreams.